ID-Clinical - personnel resourcing specialists for the Pharmaceutical, Biotechnology and Clinical Research industry.
 

ID-Clinical Candidates Job - Senior Regulatory Affairs Associate


Reference IDSS900103DP
Title Senior Regulatory Affairs Associate
Description Act as regulatory project lead/manager on assigned projects by coordinating regulatory workflow, providing regulatory support to the team, and tracking project timelines and budget. Provide ongoing regulatory support to the project team. Interface with clients and regulatory authorities as appropriate. Under limited supervision, design and complete/compile regulatory development plans and regulatory submissions. Review and format key technical documents (pertaining to clinical, chemistry, manufacturing and controls, and nonclinical information). Participate in assigned Regulatory Operations initiatives aimed at improving internal standards and systems.

Responsibilities:

  • Manage project team, timelines, budgets and deliverables with limited supervision. Utilize Microsoft Project or other appropriate tool to maintain timelines for project.
  • Present regulatory/technical information at meetings.
  • Review and approve investigator Site Regulatory Package documents (Statement of Investigator, investigator CVs, IRB/IEC approval documentation, consent forms, etc.). Work with the appropriate project team members to resolve queries.
  • Under limited supervision, design and complete strategic regulatory development plans for assigned projects, and interface with clients as needed.
  • Conduct critical reviews of key technical documents (including nonclinical and clinical development plans, protocols and reports, pre-existing regulatory dossiers and related documentation), aiming to ensure the completeness, scientific accuracy, regulatory compliance, consistency with other key documents, and ease of review.
  • Prepare, review, and compile regulatory applications including investigational and marketing applications (IND, CTA, CTX, NDA, BLA, NDS, MAA, etc.), amendments, supplements, periodic reports, annual reports, and drug master files.
  • Summarize, tabulate, and format technical information (chemistry, pharmacy, nonclinical, and clinical) per regulations/guidelines to support regulatory applications.
  • Organize any necessary translations, and translate documents if qualified.
  • Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline areas relevant to assigned projects.
  • Interface with regulatory authorities on strategic regulatory and technical matters, as appropriate.
  • Participate in Regulatory Operations meetings and training initiatives, project team meetings, and maintain relationships with other departments, and clients. Mentor new staff as appropriate.
  • Supervise key internal company regulatory initiatives.
  • Initiate efforts to generate business leads (client networking, public speaking, etc.).

Qualifications:

College degree required, preferably in a technical/scientific discipline.
Salary Excellent package offered
Location Europe, UK
Contact david.proudfoot@id-ss.com

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